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Studie av Daraxonrasib og Daraxonrasib + GnP som førstelinjebehandling hos pasienter med metastatisk pankreascellekarsinom (RASolute 303)

30. september 2026 oppdatert av: Revolution Medicines, Inc.

RASolute 303: En fase 3 global, multinasjonal, åpen, randomisert, 3-armet studie av daraxonrasib monoterapi eller daraxonrasib pluss gemcitabin og nab-paclitaxel versus gemcitabin og nab-paclitaxel som første-linje behandling for pasienter med metastatisk pankreascellekarsinom

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).

Studietype

Intervensjonell

Registrering (Antatt)

900

Fase

  • Fase 3

Utvidet tilgang

Godkjent for salg til publikum. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Revolution Medicines Study Director
  • Telefonnummer: 1-844-2-REVMED
  • E-post: medinfo@revmed.com

Studiesteder

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Rekruttering
        • St. George Hospital
      • Randwick, New South Wales, Australia, 2031
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Rekruttering
        • Royal Brisbane and Women's Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
      • Heidelberg, Victoria, Australia, 3084
        • Rekruttering
        • Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
  • Belgia
      • Anderlecht, Belgia, 1070
        • Rekruttering
        • Institut Jules Bordet
      • Leuven, Belgia, 3000
        • Rekruttering
        • UZ Leuven (Univ Ziekenhuis Leuven)
  • Brasil
      • São Paulo, Brasil, 09060-650
        • Rekruttering
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brasil, 88034-000
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Rekruttering
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Rekruttering
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Rekruttering
        • McGill University - Dept. Oncology Clinical Research Program
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85054
        • Aktiv, ikke rekrutterende
        • Mayo Clinic - Scottsdale
      • Scottsdale, Arizona, Forente stater, 85258
        • Aktiv, ikke rekrutterende
        • Honor Health Research Institute
    • California
      • Los Angeles, California, Forente stater, 90095
        • Aktiv, ikke rekrutterende
        • University of California Los Angeles Health - Hematology/Oncology
      • San Francisco, California, Forente stater, 94158
        • Aktiv, ikke rekrutterende
        • University of California San Francisco
    • Florida
      • Jacksonville, Florida, Forente stater, 32224
        • Aktiv, ikke rekrutterende
        • Mayo Clinic Cancer Center- Florida
      • Tampa, Florida, Forente stater, 33612
        • Aktiv, ikke rekrutterende
        • H Lee Moffitt Cancer Center and Research Institute
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Aktiv, ikke rekrutterende
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Aktiv, ikke rekrutterende
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Aktiv, ikke rekrutterende
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Aktiv, ikke rekrutterende
        • Mayo Clinic Cancer Center- Rochester
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Aktiv, ikke rekrutterende
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Forente stater, 10065
        • Aktiv, ikke rekrutterende
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Aktiv, ikke rekrutterende
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Aktiv, ikke rekrutterende
        • University of Cincinnati Cancer Center
      • Maumee, Ohio, Forente stater, 43537
        • Aktiv, ikke rekrutterende
        • Taylor Cancer Research Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Aktiv, ikke rekrutterende
        • SCRI Oncology Partners
    • Texas
      • Dallas, Texas, Forente stater, 95246
        • Aktiv, ikke rekrutterende
        • SCRI - Texas Oncology Dallas
      • Houston, Texas, Forente stater, 77030
        • Aktiv, ikke rekrutterende
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Aktiv, ikke rekrutterende
        • Huntsman Cancer Institute
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Aktiv, ikke rekrutterende
        • Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Aktiv, ikke rekrutterende
        • Virginia Mason Medical Center
  • Hong Kong
    • Sha Tin
      • Hong Kong, Sha Tin, Hong Kong
        • Rekruttering
        • The Chinese University of Hong Kong
  • Italia
      • Milan, Italia, 20133
        • Rekruttering
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Padova, Italia, 35128
        • Rekruttering
        • Istituto Oncologico Veneto IRCCS
      • Roma, Italia, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Tricase, Italia, 73039
        • Rekruttering
        • Azienda Ospedaliera Card. G. Panico
      • Verona, Italia, 37134
        • Rekruttering
        • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
  • Japan
      • Chiba, Japan, 260-8717
        • Rekruttering
        • Chiba Cancer Center
      • Fukuoka, Japan, 812-8582
        • Rekruttering
        • Kyushu University Hospital
      • Fukuoka, Japan, 811-1395
        • Rekruttering
        • NHO Kyushu Cancer Center
        • Ta kontakt med:
          • Terumasa Hisano
          • Telefonnummer: +81-92-541-3231
      • Kanagawa, Japan, 241-0815
        • Rekruttering
        • Kanagawa Cancer Canter
        • Ta kontakt med:
          • Makoto Ueno
          • Telefonnummer: +81-45-520-2222
      • Osaka, Japan, 541-8567
        • Rekruttering
        • Osaka International Cancer Institute
      • Tokyo, Japan, 104-0045
        • Rekruttering
        • National Cancer Center - Tokyo
      • Wakayama, Japan, 641-8510
        • Rekruttering
        • Wakayama Medical University Hospital
        • Ta kontakt med:
          • Reiko Ashida
          • Telefonnummer: +81-73-447-2300
      • Yamaguchi, Japan, 755-8505
        • Rekruttering
        • Yamaguchi University Hospital
        • Ta kontakt med:
          • Tatsuya Ioka
          • Telefonnummer: +81-836-22-2111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Rekruttering
        • National Cancer Center - East
        • Ta kontakt med:
          • Masafumi Ikeda
          • Telefonnummer: +81-4-7133-1111
    • Tokyo
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Rekruttering
        • Cancer Institute Hospital - Japan Foundation for Cancer Research
        • Ta kontakt med:
          • Masato Ozaka
          • Telefonnummer: +81-3-3520-0111
  • Nederland
      • Rotterdam, Nederland, 3015 GD
        • Rekruttering
        • Erasmus Medisch Centrum
        • Ta kontakt med:
          • Marjolein Yvonne Veronique Homs
          • Telefonnummer: +31 (0)10 704 17 54
          • E-post: m.homs@erasmusmc.nl
      • Utrecht, Nederland, 3543 AZ
  • Singapore
      • Singapore, Singapore, 168583
        • Rekruttering
        • National Cancer Centre Singapore
        • Ta kontakt med:
      • Singapore, Singapore, 217562
  • Spania
      • Madrid, Spania, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28009
        • Rekruttering
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spania, 28064
        • Rekruttering
        • Hospital Universitario La Paz - PPDS
      • Valencia, Spania, 46010
        • Rekruttering
        • Hospital Clínico Universitario de Valencia
  • Storbritannia
      • Birmingham, Storbritannia, B15 2TH
        • Rekruttering
        • Queen Elizabeth Hospital - Birmingham
      • Cambridge, Storbritannia, CB2 0QQ
        • Rekruttering
        • NHS Cambridge of Addenbrooke Hospital
      • Liverpool, Storbritannia, L7 8YA
        • Rekruttering
        • The Clatterbridge Cancer Centre
      • London, Storbritannia, W1G 6AD
      • London, Storbritannia, NW3 2QG
        • Rekruttering
        • Royal Free Hospital
      • London, Storbritannia, SE1 9RT
      • London, Storbritannia, SW3 6JJ
        • Rekruttering
        • Royal Marsden Hospital - London
      • London, Storbritannia, WC1E 6AG
        • Rekruttering
        • University College London Hospital
      • London, Storbritannia, EC1A 7BE
        • Rekruttering
        • Barts Hospital
      • Manchester, Storbritannia, M20 4BX
        • Rekruttering
        • The Christie NHS Foundation Trust
    • Devon
      • Torquay, Devon, Storbritannia, TQ2 7AA
        • Rekruttering
        • Torbay Hospital
  • Sør -Korea
      • Busan, Sør -Korea, 49201
        • Rekruttering
        • Dong-A University Hospital
      • Seoul, Sør -Korea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 03722
        • Rekruttering
        • Severance Hospital, Yonsei University Health System
      • Seoul, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center - PPDS
    • Republic of Korea
      • Daegu, Republic of Korea, Sør -Korea, 41404
        • Rekruttering
        • Kyungpook National University Chilgok Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Rekruttering
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • Rekruttering
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Rekruttering
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Rekruttering
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100225, R.O.C
        • Rekruttering
        • National Taiwan University Hospital
  • Tyskland
      • München, Tyskland, 81377
        • Rekruttering
        • Klinikum der Universitaet Muenchen Campus Grosshadern
  • Østerrike
      • Vienna, Østerrike, 1020
        • Rekruttering
        • Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented RAS mutation status, either mutant or wild-type.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

Exclusion Criteria:

  • Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
  • Active or known history of untreated central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study drug.
  • Major surgery within 28 days prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A: daraxonrasib

study drug
Legemiddel: daraxonrasib

oral tablets
Eksperimentell: Arm B: daraxonrasib + gemcitabine and nab-paclitaxel

study drug in combination with chemotherapy
Legemiddel: nab-paclitaxel

IV infusion

Legemiddel: daraxonrasib

oral tablets

Legemiddel: gemcitabine

intravenous (IV) infusion
Aktiv komparator: Arm C: gemcitabine and nab-paclitaxel

SOC chemotherapy
Legemiddel: nab-paclitaxel

IV infusion

Legemiddel: gemcitabine

intravenous (IV) infusion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression free survival (PFS)
Tidsramme: Up to approximately 2 years

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
Up to approximately 2 years
Overall survival (OS)
Tidsramme: Up to approximately 2 years

OS is defined as the time from randomization until death from any cause.
Up to approximately 2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: Up to approximately 2 years

Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.
Up to approximately 2 years
Duration of response (DOR)
Tidsramme: Up to approximately 2 years

DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.
Up to approximately 2 years
Concentration of daraxonrasib in Arm A and B
Tidsramme: Up to Cycle 5 Day 1 (each cycle is 28 days)

Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.
Up to Cycle 5 Day 1 (each cycle is 28 days)
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)
Tidsramme: Up to approximately 2 years

EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden.
Up to approximately 2 years
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Tidsramme: Up to approximately 2 years

EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning.
Up to approximately 2 years
Incidence of adverse events (AEs)
Tidsramme: Up to approximately 2 years

Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Up to approximately 2 years
Changes in vital signs
Tidsramme: Up to approximately 2 years

Number of patients with clinically significant changes in vital signs
Up to approximately 2 years
Changes in clinical laboratory test values
Tidsramme: Up to approximately 2 years

Number of patients with changes from baseline in clinical laboratory test values
Up to approximately 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Revolution Medicines, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. mars 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. mars 2029

Datoer for studieregistrering

Først innsendt

10. mars 2026

Først innsendt som oppfylte QC-kriteriene

19. mars 2026

Først lagt ut (Faktiske)

24. mars 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RMC-6236-303

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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